K880476 is an FDA 510(k) clearance for the LYME DISEASE ELISA. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on April 26, 1988, 82 days after receiving the submission on February 4, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K880476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1988 |
| Decision Date | April 26, 1988 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |